Characterization and Comparative Investigation of Hydroxyapatite/Carboxymethyl Cellulose (CaHA/CMC) Matrix for Soft Tissue Augmentation in a Rat Model.

Abstract

This study endeavors to develop an injectable subdermal implant material tailored for soft tissue repair and enhancement. The material consists of a ceramic phase of calcium hydroxyapatite (CaHA), which is biocompatible, 20-60 μm in size, known for its biocompatibility and minimal likelihood of causing foreign body reactions, antigenicity, and minimal inflammatory response, dispersed in a carrier phase composed of carboxymethyl cellulose (CMC), glycerol, and water for injection. The gel formulation underwent comprehensive characterization via various analytical techniques. X-ray diffraction (XRD) was employed to identify crystalline phases and investigate the structural properties of ceramic particles, while thermogravimetric analysis (TGA) was conducted to evaluate the thermal stability and decomposition behavior of the final formulation. Scanning electron microscopy (SEM) was utilized to examine the surface morphology and particle size distribution, confirming the homogeneous dispersion of spherical CaHA particles within the matrix. SEM analysis revealed particle sizes ranging from approximately 20-60 μm. Elemental analysis confirmed a stoichiometric Ca/P ratio of 1.65 in the hydroxyapatite (HA) structure. Heavy metal content exhibited suitability for surgical implant use without posing toxicity risks. Rheological analysis revealed a storage modulus of 58.6 and 68.9 kPa and a loss modulus of 21.7 and 24.8 kPa at the frequencies of 2 and 5 Hz, respectively. 150 μL of sterilized CaHA/CMC was injected subcutaneously into rats and compared with a similar product, Crystalys, to assess its effects on soft tissues. Skin tissue samples of rats were collected at specific intervals throughout the study (30, 45, 60, 90 and 120 days), and examined histologically. Results demonstrated that CaHA/CMC gel led to a significant increase in dermal thickness, elastic fibers, and collagen density. Based on the findings, the formulated CaHA/CMC gel was found to be biocompatible, biodegradable, nonimmunogenic, nontoxic, safe, and effective, and represents a promising option for soft tissue repair and augmentation.